Training Programs

MWA provides customized and standardized training on a wide variety of GXP topics. Training programs are continuously updated so that the training reflects current regulatory thinking. Training is available via teleconference or onsite based on your needs. Download our course descriptions or view them below:

Aseptic Techniques Course Objectives:
• Review the GMP requirements for aseptic practices
• Reinforce the use of aseptic practices in the clean room during the manufacturing process
1.5 hours

CGMP for Phase 1 Investigational DrugsCourse Objectives:
• Review the new guidance document issued by FDA and what it means
• Interpretation of the guidance
• Discuss where controls are needed
• Identify what is non-negotiable for Phase 1 investigational drugs
1 hour

FDA QSIT Audit ApproachCourse Objectives:
• Review the FDA QSIT approach to inspection for pharmaceuticals
• Understand the FDA requirements expected for each quality subsystem
• Review the FDA rating system for failures in the quality system and the implications
2.5 hours

FDA Regulations (GMP, GCP and GLP)Course Objectives:
• Overview of quality and requirements for working in a regulated industry
• Overview of CGMP,GLP, GCP regulations and practical interpretation of the requirements
• Review of pertinent 483 observations related to either cGMPs, GLPs or GCPsLength of time determined by the detail of the program and customization per client needs

GMP/QSR TrainingCourse Objectives:
Overview of CGMP,QSR, or combination of both regulations
• Understand key definitions
• Review of pertinent 483 observationsLength of time determined by the detail of the program and can be customized to your needs

GMPs in Research and DevelopmentCourse Objectives:
• Understand what the GMP requirements are within research and development
• Review how the GMPs evolve through the development process
• Provide an overview of data integrity
• Learn how to provide a solid basis for development documentation that serves as the foundation for the development history report
• Review and discuss Warning Letters
2 hours

GMPs in Research and DevelopmentCourse Objectives:
• Understand what the GMP requirements are within research and development
• Review how the GMPs evolve through the development process
• Provide an overview of data integrity
• Learn how to provide a solid basis for development documentation that serves as the foundation for the development history report
• Review and discuss Warning Letters
2 hours

Interacting with FDACourse Objectives:
• Interacting with FDA
• Discuss what the FDA looks for during an inspection
• Review key techniques for effectively interacting with the FDA
• Provide the “do’s” and “don’ts” of interacting with the FDA
1.5 hours

Internal and External Auditing Techniques
Course Objectives:
We train your audit team to prepare, conduct, and follow-up internal audits. We reference your SOPs and can provide supervised practice time for new auditors.Length of time determined by the detail of the program

ISO 13485:2003Course Objectives:
• Review ISO 13485 in detail and discuss the outputs based on the requirement
2 hours